6. UDI Compliance Workflow: Ensuring Your Mark Passes the Test Simply buying a laser machine isn’t enough. To be FDA compliant, your marking process must be validated. At HeatSign, we recommend the following 4-step workflow for surgical steel manufacturers: Step 1: Pre-Marking Passivation (Optional but Recommended) Clean the instrument to remove all oils and contaminants from the machining process. Step 2: Laser Annealing with MOPA Using a HeatSign HS-FL-MOPA system, mark the DataMatrix code (UDI) and human-readable text. The parameters must be set to “Anneal” mode to ensure zero surface penetration. Step 3: Post-Marking Passivation The instrument is placed in a Citric or Nitric Acid bath. This step is critical. The acid...